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NCT06651580Recruiting

Biospecimen Collection to Identify Gene Mutations for High Risk Pancreatic Cancer in Pediatric Patients, INSPPIRE 2 Study

Pediatric Longitudinal Cohort Study of Chronic Pancreatitis (INSPPIRE 2)

Source: ClinicalTrials.gov · Last updated 11 Sept 2026

Brief summary (registry, in English)

This clinical trial collects blood, saliva, urine, or stool samples to help identify possible genetic mutations that may increase a person's chance at developing pancreatic cancer. Finding genetic markers among pediatric patients with acute recurrent pancreatitis and chronic pancreatitis may help identify patients who are at risk of pancreatic cancer.

Status (registry)
Recruiting
Study type
Observational
Enrollment
1600 (estimated)
First submitted
18 Oct 2024
Start date
1 Apr 2021
Primary completion date
2 Feb 2027
Lead sponsor
M.D. Anderson Cancer Center
NCT number
NCT06651580

What you commit to

  • Study type: Observational
  • Planned participants: 1600
  • From 1 Apr 2021 to the primary completion date, 2 Feb 2027
  • 26 sites in 4 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • Subjects must not have any significant medical illnesses that in the investigator's opinion cannot be adequately controlled with appropriate therapy or would compromise the subject's ability to tolerate study interventions

Who the study is looking for

  • All subjects/parents must sign an informed consent and/or assent indicating that they are aware of the investigational nature of this study
  • Subjects/parents must have signed an authorization for the release of their or their child's protected health information
  • All children must be under 18 years of age at the time of enrollment
  • All children providing samples should fit the ARP or CP inclusion criteria defined below:
    • Acute pancreatitis (AP): AP is defined as requiring 2 of the following:
    • Abdominal pain compatible with AP
    • Serum amylase and/or lipase values \>= 3 times upper limits of normal
    • Imaging findings of AP, such as gland enlargement, acute inflammatory changes, and fluid collections
    • ARP is defined as: At least 2 episodes of acute pancreatitis with complete resolution of pain and a \>= 1 month pain-free interval between episodes
    • Chronic Pancreatitis:
    • Children with at least:
    • One irreversible structural change in the pancreas with or without abdominal pain +/- exocrine pancreatic insufficiency +/- diabetes
    • Irreversible structural changes:
    • Ductal calculi, dilated side branches, parenchymal calcifications found in any imaging (abdominal ultrasound \[abd US\], magnetic resonance imaging/magnetic resonance cholangiopancreatography \[MRI/MRCP\], computerized tomography \[CT\], endoscopic retrograde cholangiopancreatography \[ERCP\], endoscopic US \[EUS\])
    • Ductal obstruction or stricture/dilatation/irregularities that are persistent (for \>= 2 months) on any imaging
    • Parenchymal atrophy, irregular contour, accentuated lobular architecture, cavities alone are not diagnostic findings for CP
    • Surgical or pancreatic biopsy specimen demonstrating histopathologic features compatible with CP (acinar atrophy, fibrosis, protein plugs, infiltration with lymphocytes, plasma cells, macrophages)

Age in the registry: - to 17 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (26)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Sydney Children's Hospital
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RandwickAustraliaRecruiting
The Montreal Children's Hospital of the MUHC
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MontrealCanadaRecruiting
Hospital for Sick Children
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TorontoCanadaRecruiting
Hadassah University Hospital
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JerusalemIsraelRecruiting
Emory University Hospital/Winship Cancer Institute
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AtlantaUnited StatesRecruiting
Johns Hopkins University/Sidney Kimmel Cancer Center
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BaltimoreUnited StatesRecruiting
Boston Children's Hospital
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BostonUnited StatesRecruiting
Cincinnati Children's Hospital Medical Center
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CincinnatiUnited StatesRecruiting
Nationwide Children's Hospital
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ColumbusUnited StatesRecruiting
University of Texas Southwestern/Children's Medical Center
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DallasUnited StatesRecruiting
University of Colorado
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DenverUnited StatesRecruiting
Texas Children's Hospital
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HoustonUnited StatesRecruiting
M D Anderson Cancer Center
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HoustonUnited StatesRecruiting
Riley Hospital for Children
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IndianapolisUnited StatesRecruiting
University of Iowa/Holden Comprehensive Cancer Center
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Iowa CityUnited StatesRecruiting
Cedars-Sinai Medical Center
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Los AngelesUnited StatesRecruiting
Children's Hospital Los Angeles
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Los AngelesUnited StatesRecruiting
Children's Hospital of Wisconsin
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MilwaukeeUnited StatesRecruiting
University of Minnesota/Masonic Children's Hospital
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MinneapolisUnited StatesRecruiting
Ochsner Medical Center Jefferson
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New OrleansUnited StatesRecruiting
UCSF Benioff Children's Hospital Oakland
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OaklandUnited StatesRecruiting
Stanford Cancer Institute Palo Alto
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Palo AltoUnited StatesRecruiting
Children's Hospital of Philadelphia
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PhiladelphiaUnited StatesRecruiting
Children's Hospital of Pittsburgh of UPMC
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PittsburghUnited StatesRecruiting
Children's Hospital of San Antonio
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San AntonioUnited StatesRecruiting
Washington University School of Medicine
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St LouisUnited StatesRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.